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. 2025 May;17(10):661-669.
doi: 10.1080/17576180.2025.2506349. Epub 2025 May 15.

LC-MS/MS determination of trazodone in human plasma and its pharmacokinetic study in healthy Chinese

Kaiwei Luo  1 , Danrui Liu  1 , Shengshuo Zhang  1 , Xin Zhang  1 , Qunan Cheng  1 , Jie Lin  1 , Yonghua Yu  1
Affiliations

LC-MS/MS determination of trazodone in human plasma and its pharmacokinetic study in healthy Chinese

Kaiwei Luo et al. Bioanalysis. 2025 May.

Abstract

Aims: This study aimed to establish a robust LC-MS/MS method for quantifying trazodone in human plasma and investigate its pharmacokinetic profile in healthy Chinese subjects under fasting and fed conditions.

Materials & methods: A validated LC-MS/MS method using protein precipitation was applied to analyze trazodone in 68 healthy subjects (34 fasting/34 fed), with full method validation performed.

Results: This method exhibited high selectivity, precision, and accuracy. The results showed good linearity in the range of 5-3000 ng/mL and matrix effect results showed no matrix interference. The pharmacokinetic data revealed notable differences between the fasting and postprandial states.

Conclusions: The validated LC-MS/MS method proved reliable for trazodone quantification. The observed food effects on absorption suggest clinical dosing should consider administration conditions to ensure optimal therapeutic outcomes.

Keywords: LC-MS/MS; Trazodone hydrochloride; internal standard; isotopic trazodone-d6; methodology validation; pharmacokinetic.

Plain language summary

Trazodone hydrochloride is a medicine used to treat depression and sleep problems. To understand how the body processes this drug, we developed a method to measure how much trazodone is in the blood after taking it. We tested this method on healthy adults who took the medicine either with food or on an empty stomach. Our study found that eating before taking trazodone slows down how quickly the drug is absorbed, but does not change the total amount the body receives. No serious side effects were observed. This information helps doctors decide the best way for patients to take trazodone and shows that our testing method works well for future medical studies.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

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